As we all know, molecular radiotherapy (MRT) is a highly multidisciplinary area, or at least should be if safe and effective treatment is intended. Nuclear Medicine is at the heart of MRT with expertise in radiochemistry, imaging and physics as well as clinical experience. This is a rapidly expanding area and the BNMS are maintaining a high profile in the field.
In recent years a number of groups have emerged to address particular aspects of this under-utilised (and largely misunderstood) cancer treatment. The BNMS have undertaken to promote cohesion between these groups and in October held a second ‘umbrella group’ tcon of stakeholders that included representation from CERT (CRUK / ECMC), CTRad, IDUG, the HPA, UKRG, the NPL, IPEM and the RCR. Each group presented achievements and activities. CERT have developed a website to help researchers negotiate regulatory hurdles in the development of radiotherapeutics (http://www.ecmcnetwork.org.uk/network-groups/cert-group/)
The NPL continue with their MetroMRT Euramet programme, led by Vere Smyth, with the aim of standardising internal dosimetry. Joe O’Sullivan reported for CTRad that a project manager is to be employed to assess the current status of research in MRT. This follows a perceived lack of support from funding bodies including the CRUK in this area.
The BNMS successfully petitioned for inclusion in the Radiotherapy Board and presented the current status of MRT in the UK at a meeting in October. The lack of reimbursement for therapy procedures and the need for evidence-based trials were among the issues highlighted. This has led to a sub group of the Radiotherapy Clinical Reference Group concerned MRT, which will be chaired by Margaret Hall and will include Glenn Flux, Val Lewington, Matt Guy and Louise Fraser as well as representatives from clinical oncology.
The recent iSTARD track within the EANM annual congress proved to be a huge success with full sessions concentrated on therapy and dosimetry. Particular interest was seen in novel radiotherapeutics, including PET/CT and SPECT/CT diagnostic imaging and therapeutic possibilities for radiolabelled PSMA.
Following the success of a combined BNMS/RSM meeting in March of this year, the BNMS will hold a 1 day meeting on MRT in the Autumn of 2015. Details to follow.
The NCRI thyroid group recently held a project meeting to consider trial proposals for thyroid cancer treatments. Proposals included a prospective dosimetry data collection for patients with medium to high risk thyroid cancer to determine whether a dose-effect relationship can be found. A possible option for this study is to perform tracer studies to determine whether a critical absorbed dose to effect a complete response can be found could be planned prior to treatment.
Mark Gaze reported at the umbrella group meeting that the LuDo trial currently being run at the UCLH to determine the potential for PRRT treatment of children with neuroblasatoma, has so far recruited 6 patients.
Mark Gaze also reported progress in the development of a Europe wide trial of the treatment of relapsed and refractory neuroblastoma with I-131 mIBG (Veritas).This trial has been in discussion and preparation for over a decade.
Kim Orchard reported at the same meeting that the trials of Y-90 labelled anti-CD66 for haematopoietic stem cell transplantation is open and is aiming to recruit 55 allogenic transplant patients. This treatment incorporates dosimetry to optimise treatment.
CTAAC are currently evaluating a proposal from PI Jon Wadsley (Sheffield) to use selumetinib, a MEK inhibitor, for iodine refractory patients. Patients will be scanned with I-123 NaI prior to and after a course of selumetinib and will receive therapy if the NIS expression has increased sufficiently.
As noted by Sarah Allen at the umbrella meeting, costs for clinical trials with radiotherapeutics are entirely subject to the vagaries of current practice. Centres currently performing imaging for dosimetry as ‘standard of care’ would have costs reimbursed from local PCTs, whereas centres starting a new service would require funding to participate or launch new trials.
The Technology appraisal group of NICE considered Ra-223 (Xofigo) at a meeting on 12th November. The company had submitted figures for the administration and monitoring of Ra-223 that were comparable with those for abiraterone. The BNMS, although not invited to attend, submitted opinions that (i) cost and resource implications for handling and administering Ra-223 had not been fully taken into account, (ii) there was no indication of how the EU directive 2013/59 would be addressed and (iii) that the current lack of a UK registry meant that there would be no record of the centres offering this treatment, nor of outcome data. The first issue was discussed at the technology appraisal meeting and the panel heard that costs would indeed not be greater for Ra-223 than for abiraterone (£161), and that the main problem for the Nuclear Medicine community is that they are not receiving the reimbursement that is given to the centres. This is of course a major issue for nuclear medicine in the UK, as there are more commercial radiotherapeutics in development or in early phase clinical trials. A recent survey from IDUG, soon to be published, found that in 2011 111 treatments for bone metastases from prostate cancer were treated with radiopharmaceuticals in UK. We have already seen a massive growth in Ra-223 treatments in the last year, and the company have estimated that with NICE approval 2000 patients would be eligible for treatment each year in the UK, which would amount to 12000 treatments. General guidance on Ra-223 has been produced by the UKRG: (http://www.bnms.org.uk/images/stories/UKRG/2014/Addendum_to_Safe_Drawing_up_document_for_223Ra_Radium_Chlor1.pdf). A decision from NICE is expected in the first week of December.
Sirtex have completed an international study to explore the possibilities of PET/CT based dosimetry for the treatment of liver cancers and metastases with Y-90 resin microspheres. This will be followed by a clinical trial.
BTG are rumoured to be also exploring the potential of dosimetry for similar treatments with Y-90 glass microspheres.
While in the UK treatments with external beam radiotherapy or chemotherapy are recorded, this information does not exist for MRT. The BNMS have been in negotiation with NATCANSAT, responsible for the national Radiotherapy Dataset (RTDS), who have agreed to pilot a national registry. The cost for this would be £7000. Ideas for fundraising would be welcomed.
The EU directive 2013/59 mandates dosimetry based treatment planning for all radiotherapeutics, ‘including Nuclear Medicine for therapeutic purposes’. This directive mandates that ‘Member states shall bring into force the laws, regulations and administrative provisions necessary to comply with this directive by 6th February 2018.’ It is evident that the use of radiotherapeutics to treat cancer is on the threshold of a massive expansion which presents both major challenges and major opportunities to Nuclear Medicine.
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